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CTDe, CTD the challenge and success seminar
 
 
CTD/eCTD the challenge & success seminar (18th-20th October 2010 – Cairo/Egypt)
 
This seminar starts by highlighting the experience of selected countries 
in the area and extends itself to some EU authorities experiences regarding CTD/eCTD.
The seminar then continues to discuss and explain the required content and related standards
by recognized international authorities through the contribution of international experts. 
The CTD format and handling is further explained by major providers of CTD publishing providers
and experts on CTD publishing.
 
- Seminar themes: 
 
1.Egypt MOH policies
2.EU policies and experience
3.Review of implementing eCTD at Swissmedic
4.Introduction to CTD content
a. Structure of the CTD (Module 1 – 5)
a.a. Relevant guidance  documents
b.a Simplifications in case of bibliographic or generic products
B. Electronic submissions
a.b Current guidance documents
b.b eCTD
5. Quality documentation (CTD – Module 3)
a. Drug (active) Substance properties and pre-formulation studies
a.a Active Substance Master File
b.a EU - Certificate of Suitability
B. Stability Testing ICH Q1A
C. Setting of specifications ICHQ6A
6.Quality documentation (CTD – Module 3) - important technical sections 
1.Modern approaches to Pharmaceutical development (P2) 
2.Quality Risk Management
3.How to implement Quality Risk Management in a dossier & Example
7.Quality Risk Management Plan
8.Variation procedures
1.Legal provisions – key issues of the new EU Variation Regulation
2.Classification Type IA/IB/II/extension
9.Impurity Testing : important elements
1.Impurities in drug substance ICH Q3A
2.Degradation products in drug products ICH Q3B
3.Residual solvents ICH Q3C
4.Residual metals  
5.Genotoxic impurities
10.Clinical documentation 
1.Clinical Summary and Overview
2.CTD – Module 5 - important technical sections
a.Biopharmaceutical studies
b.Efficacy
c.Safety
d.Bibliographical data
11.Non-Clinical documentation 
1.Non-Clinical Summary and Overview
2.CTD – Module 4 - important technical sections
a.Genotoxicity
b.Carcinogenicity
c.Reproductive and Developmental Toxicity
d.Special aspects for biotech products
12.How Swissmedic handles eCTD submissions
13.Practical eCTD training: Dossier compilation & Publishing for companies.
14.Authority practical eCTD training
15.Review eCTD files
 
Speakers: 
 
- Dr. Ashraf Bayomi, 
- Dr Christa Wirthumer-Hoche 
- Dr. Klaus Menges, 
- Dr. Stephan Jarmann 
- Dr. Fritz Erni